Results

CUPERTINO, Calif., Aug. 3 /PRNewswire-FirstCall/ -- DURECT Corporation (Nasdaq: DRRX) announced today financial results for the three months ended June 30, 2009. Total revenues were $4.9 million for the three months ended June 30, 2009, compared to $6.3 million for the same period in 2008. Net loss for the three months ended June 30, 2009 was $7.5 million, compared to a net loss of $8.6 million for the same period in 2008.

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At June 30, 2009, DURECT had cash and investments of $41.9 million, compared to cash and investments of $52.7 million at December 31, 2008; these figures include restricted investments of $0.8 million at June 30, 2009 and $1.0 million at December 31, 2008.

"Our senior management team was strengthened during the second quarter through the hiring of Joe Stauffer as our Chief Medical Officer, a former anesthesiologist and FDA reviewer with directly relevant experience covering all aspects of developing pain medications," stated James E. Brown, D.V.M., President and CEO of DURECT. "It is also noteworthy that we signed four new feasibility projects in the quarter with pharmaceutical companies to apply our SABER(TM) depot and DURIN(TM) injectable technologies to address specific drug delivery challenges for both small molecule and biologic agents. Shortly after the end of the quarter, we were pleased to learn that King Pharmaceuticals met with the FDA regarding Remoxy(R) and believes that they have a clear path forward that could allow them to resubmit the Remoxy NDA in mid-2010."

Recent Highlights:

    -- Remoxy.  Pain Therapeutics, our licensee, received a Complete Response
       Letter from the FDA in December 2008 indicating that the NDA is not
       approved in its present form.  King Pharmaceuticals, the
       commercialization partner of Pain Therapeutics for Remoxy, assumed
       responsibility for further development of Remoxy from Pain
       Therapeutics in March 2009 and met with the Food and Drug
       Administration (FDA) on July 2, 2009 to discuss the Complete Response
       Letter.  According to King Pharmaceuticals and Pain Therapeutics, the
       outcome of that meeting provided King with a clear path forward to
       resubmit the REMOXY NDA and to address all FDA comments in the
       Complete Response Letter.  According to the King Pharmaceuticals /
       Pain Therapeutics press release, King now anticipates the
       resubmission of the NDA could occur mid-year 2010.  King has stated
       that it remains committed to the development and commercialization of
       REMOXY and looks forward to working closely with the FDA toward
       approval of the product.
       REMOXY, an investigational drug, is a long acting oral formulation of
       oxycodone intended to treat moderate to severe pain. Based on DURECT's
       ORADUR(R) technology, which is covered by issued patents and pending
       patent applications owned by us, REMOXY is designed to resist common
       methods of prescription drug misuse and abuse.

    -- POSIDUR(TM) (SABER(TM)-Bupivacaine).  During the quarter, DURECT continued
       enrollment in our approximately 60 patient Phase IIb clinical study in
       shoulder surgery.  In addition, Nycomed continued enrollment in a
       Phase IIb study in hysterectomy patients and a Phase IIb study in
       shoulder surgery patients.  We are in active discussions with multiple
       potential partners regarding licensing of the U.S./Canada and Asian
       rights to this program.
       POSIDUR is our investigational post-operative pain relief depot that
       utilizes our patented SABER technology to deliver bupivacaine to
       provide up to three days of pain relief after surgery. POSIDUR is
       licensed to Nycomed for commercialization in Europe and select other
       countries, and we have retained commercialization rights in the US,
       Canada and Asia.

    -- ELADUR(TM) (TRANSDUR(TM)-Bupivacaine).  In October 2008, worldwide rights to
       this program were licensed to Alpharma, which was acquired by King
       Pharmaceuticals in December 2008.  During the second quarter, we
       continued to interact with the King team on details associated with
       next steps in the clinical program, which King expects to initiate
       this year.
       ELADUR is our proprietary transdermal patch intended to provide
       bupivacaine for a period of up to three days from a single
       application.
    -- TRANSDUR-Sufentanil.  A successful end-of-Phase II meeting with the
       FDA has been conducted for this program that laid out a potential
       regulatory pathway for the Phase III program and approval.  We are in
       active discussions with multiple potential partners regarding
       licensing development and commercialization rights to this program to
       which we hold worldwide rights.
       TRANSDUR-Sufentanil is our proprietary transdermal patch intended to
       provide sufentanil to chronic pain sufferers for a period of up to
       seven days from a single application.

    -- Feasibility Projects.